| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prevention of dengue disease in toddlers, children, and adults in endemic areas, as well as travelers to endemic areas |
|
| E.1.1.1 | Medical condition in easily understood language |
| Prevention of dengue disease |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10012309 |
| E.1.2 | Term | Dengue |
| E.1.2 | System Organ Class | 100000004862 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1. To compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes at Day 28 postvaccination for participants administered the V181 Low Potency Level versus V181 Mid Potency Level
2. To evaluate the safety and tolerability of 3 different V181 potency levels with respect to the proportion of participants experiencing serious adverse events (SAEs) |
|
| E.2.2 | Secondary objectives of the trial |
| 1. To evaluate the safety and tolerability of 3 different V181 potency levels with respect to the proportion of participants experiencing solicited adverse events (AEs) |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Is healthy based on review of medical history and physical examination, according to the clinical judgement of the investigator.
2. Is male or female, from 18 years to 50 years of age inclusive, at the time of signing the informed consent.
3. Male participants are eligible to participate if they agree to the
following for at least 90 days after administration of study intervention:
• Abstain from heterosexual intercourse as their preferred and usual
lifestyle (abstinent on a long term and persistent basis) and agree to
remain abstinent
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
OR
• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
• Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a WOCBP
OR
• Is a WOCBP and using a contraceptive method that is highly effective
(with a failure rate of <1% per year), or be abstinent from heterosexual
intercourse as their preferred and usual lifestyle (abstinent on a long
term and persistent basis), for at least 90 days after administration of
study intervention. The investigator should evaluate the potential for
contraceptive method failure (ie, noncompliance, recently initiated) in
relationship to the first dose of study intervention.
• A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
• The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
5. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research |
|
| E.4 | Principal exclusion criteria |
2. * Has an acute febrile illness (temperature ≥38.0°C [≥100.4°F] oral
or equivalent) occurring within 72 hours before receipt of study
vaccine/placebo.
3. Has a serious or progressive disease according to the investigator,
including but not limited to cancer; uncontrolled diabetes; severe
cardiac, renal, or hepatic insufficiency; or systemic autoimmune or
neurologic disorder.
4. Has known or suspected impairment of immunological function,
including but not limited to congenital or acquired immunodeficiency,
HIV infection, hematologic malignancy, or treatment for autoimmune
diseases.
5. Has a condition in which repeated venipuncture or injections pose
more than minimal risk for the participant, such as hemophilia,
thrombocytopenia, other severe coagulation disorders, or significantly
impaired venous access.
6. Has a known hypersensitivity to any component of the study
vaccine/placebo, or history of severe allergic reaction (eg, swelling of
the mouth and throat, difficulty breathing, hypotension or shock) that
required medical intervention.
7. Has received a dose of any dengue vaccine (investigational or
approved) before study entry, or plans to receive any dengue vaccine
(investigational or approved) for the duration of the trial.
8. * Has received other licensed non-live vaccines within 14 days before
receipt of study vaccine/placebo or is scheduled to receive any licensed
non-live vaccine within 28 days following receipt of study
vaccine/placebo. Exception: Inactivated influenza vaccine may be
vaccine/placebo or at least 28 days after receipt of study
vaccine/placebo.
9. * Has received a licensed live vaccine within 28 days before receipt of
study vaccine/placebo or is scheduled to receive any live vaccine within
28 days after receipt of study vaccine/placebo.
10. Has received systemic corticosteroids (equivalent of ≥2 mg/kg/day
of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14
consecutive days and has not completed treatment at least 30 days
before study entry or is expected to receive systemic corticosteroids at
aforementioned dose and duration within 28 days after receipt of study
vaccine/placebo.
11. Has received systemic corticosteroids exceeding physiologic
replacement doses (approximately 5 mg/day prednisone equivalent)
within 14 days before vaccination.
12. Has received immunosuppressive therapies, including
chemotherapeutic agents used to treat cancer or other conditions,
treatments associated with organ or bone marrow transplantation, or
autoimmune disease, within 6 months before receipt of study
vaccine/placebo or plans to receive immunosuppressive therapies within
28 days after receipt of study vaccine/placebo.
13. Has received a blood transfusion or blood products (including
immunoglobulins) within 6 months before receipt of a study
vaccine/placebo or plans to receive a blood transfusion or blood
products (including immunoglobulins) within 28 days after receipt of
study vaccine/placebo.
14. Has participated in another clinical study of an investigational
product within 6 months before signing the informed consent, or plans
to participate in another interventional clinical study at any time during
the duration of the current clinical study. Participants enrolled in
observational studies may be included; these will be reviewed on a casebycase
basis for approval by the Sponsor.
15. Has any other reason that, in the opinion of the investigator, may
interfere with the evaluation required by the study. Reasons may
include, but are not limited to, being unable to complete the eVRC, being
unable to complete visits including non-office visit contacts (eg,
telephone), or being unable to comply with study procedures.
16. Has planned donation of blood, eggs, or sperm at any time from
signing the informed consent through 90 days postvaccination.
17. Is or has an immediate family member (eg, spouse, parent/legal
guardian, sibling, or child) who is investigational site or Sponsor staff
directly involved with this study.
If a participant meets any of the exclusion criteria marked with an
asterisk (*), the Day 1 visit may be rescheduled for a time when these
criteria are no longer met, as long as the study is still open to
enrollment. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)
2. Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Day 28 postvaccination
2. Up to 28 days postvaccination
|
|
| E.5.2 | Secondary end point(s) |
1. Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
2. Percentage of Participants With Solicited Systemic AEs
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 5 days postvaccination
2. Up to 28 days postvaccination
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Immunogenicity; Potency-ranging |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Australia |
| Canada |
| Israel |
| Korea, Republic of |
| Taiwan |
| United States |
| Finland |
| Germany |
| Belgium |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The overall study ends when the last participant completes the last study-related telephone-call or visit, withdraws consent, or is lost to follow-up (ie, the participant is unable to be contacted by the investigator). |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 20 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 20 |
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